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Zambia Exclusive Breastfeeding Study

NCT00310726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1435

Last updated 2011-07-27

No results posted yet for this study

Summary

The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.

Conditions

  • HIV Infection

Interventions

OTHER

abrupt weaning at 4 months

abrupt weaning at 4 months

OTHER

Continued exclusive breastfeeding

Continued exclusive breastfeeding

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • National Institutes of Health (NIH)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Louise Kuhn, PhD · Gertrude H. Sergievsky Center, and Department of Epidemiology, Mailman School of Public Health, Columbia University

  • Donald M Thea, MD, MSc · Department of International Health, Boston University School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310726 on ClinicalTrials.gov